MAUDE Adverse Event Report: OBERDORF : SYNTHES PRODUKTIONS GMBH 12MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR; GUIDE

Catalog Number	03.802.242
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/06/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Patient weight not available for reporting.Device is an instrument and is not implanted/explanted.Complainant part is expected to be returned for manufacturer review/investigation, but has yet to be received.The investigation could not be completed; no conclusion could be drawn, as no product was received.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Device report from synthes europe reports an event in (b)(6) as follows: it was reported the tip of the 12mm aiming device modified for synfix-lr broke off during an unknown surgical procedure and became stuck in the peek (polyetheretherketone) implant.The broken tip could not be removed and remains in the patient.Concomitant device reported: peek implant (part number unknown, lot number unknown, quantity 1).(b)(4).
Additional Manufacturer Narrative
The device was received and the product evaluation is in progress.No conclusion can be drawn.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was further reported that the surgery was complete successfully.Patient outcome was reported as good.
Additional Manufacturer Narrative
Additional narrative: concomitant device reported in event description of initial medwatch.Therapy date is (b)(6) 2017.A device history record (dhr) review was performed for part no.: 03.802.242, lot no.: 9419870: manufacturing location: bettlach, release to warehouse date: 09.Apr.2015: no non-conformance reports (ncrs) were generated during production.Review of the device history record(s) showed that there were no issues during the manufacture of the product that would contribute to this complaint condition.A product investigation was performed.Reviewing dhr shows that the affected lot was released after complete final inspection with no detected issues regarding manufacturing procedure.This device was released in faultless condition.For details, please see appropriate section device history.The investigation of the complained part shows that the connecting screw of the aiming device is broken apart and the thread is missing.The broken surface is homogeneous what indicates material conformity as well.As the broken part is missing, we are not able to measure the relevant dimensions.We have to assume that exceeding applied mechanical force while use may have caused the breakage.Improper connection of the connecting screw with the cage could have caused high mechanical force while insertion what can lead to the breakage finally.No product fault could be detected.Based on the investigation findings, it has been determined that no corrective and/or preventative action is proposed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12MM AIMING DEVICE-MODIFIED FOR SYNFIX-LR
• Common Device Name: GUIDE
• Manufacturer (Section D): OBERDORF : SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 7160783
• Report Number: 8030965-2018-50036
• Device Sequence Number: 1497190
• Product Code: FZX
• UDI-Device Identifier: 07611819310940
• UDI-Public: (01)07611819310940(10)9419870
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 03.802.242
• Device Lot Number: 9419870
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/16/2018; 03/05/2018
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/29/2018; 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 49 YR